Granules Pharmaceuticals Inc.: Drug Recall

Recall #D-0510-2025 · 06/24/2025

Class II: Risk

Recall Details

Recall Number
D-0510-2025
Classification
Class II
Product Type
Drug
Recalling Firm
Granules Pharmaceuticals Inc.
Status
Ongoing
Date Initiated
06/24/2025
Location
Chantilly, VA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27,648 100-count Bottles; 5,376 500-count Bottles

Reason for Recall

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

Product Description

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,

Distribution Pattern

Nationwide in the USA.

Other Recalls by Granules Pharmaceuticals Inc.

View all recalls by Granules Pharmaceuticals Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.